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Clinical Trials/EUCTR2020-003570-49-IT
EUCTR2020-003570-49-ITActive, not recruitingPhase 1

Phase III, Open-label, Uncontrolled, Multicenter Study to Assess Efficacy, Pharmacokinetics and Safety of IMMUNORHO in the Prevention of RhD Isoimmunization in Rh(D) negative Women Pregnant with Rh(D) positive Foetuses - NA

KEDRION S.P.A0 sites276 target enrollmentStarted: June 4, 2021Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
276
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
Female

Inclusion Criteria

  • •1. Subjects who have voluntarily given written Informed Consent and Authorization to Access Personal Health Information after the nature of the study has been explained according to local regulatory requirements,
  • •prior to study entry.
  • •2. Age >=18 years at the time of screening.
  • •3. Rh(D) negative.
  • •4. Pregnancy is at 25 (from day 0 to day 7) to 26 (day 7) weeks gestation.
  • •5. Negative for anti-D antibodies.
  • •6. Carrying a Rh(D) positive (including Dweak and Dpartial) foetus as determined by antepartum foetal/maternal non-invasive genotyping.
  • •7. Individuals who can comply with study procedures.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 276
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Prior administration of RhD immunoglobulin during the current pregnancy.
  • •2. History of allergies or severe reactions to immunoglobulins or other blood products.
  • •3. Amniocentesis, chorionic villus biopsy, or cordocentesis performed or planned for the current pregnancy.
  • •4. Known clinically relevant maternal or foetal abnormality, such as placenta previa for the current pregnancy.
  • •5. Intra-operative cell salvage performed or planned for the current pregnancy.
  • •6. Blood or blood component transfusion within 6 months of study entry.
  • •7. Diagnosis of selective IgA deficiency with anti-IgA antibody.
  • •8. Participation in any interventional drug/device clinical trial within 30 days or 5 half-lives whatever is longer prior to Informed Consent.
  • •9. Any other medical condition that could interfere with study assessment or interpretation of the data.
  • •10. Multiple pregnancy.
  • •11. Live attenuated viral vaccine administration within 2-4 weeks before IMMUNORHO or planned within 3 months after the last administration of IMMUNORHO.
  • •12. History of malignancy requiring surgery, systemic therapy, or radiation within the prior 5 years or considered not in full remission (except for curatively treated basal or squamous cell carcinoma of the skin or cured cervical carcinoma-in-situ).
  • •13. In the opinion of the Investigator, have issues or concerns that may compromise the safety of the subject, impact the subject's compliance
  • •with the protocol requirements, or confound the reliability of the data acquired.
  • •14. Be a Kedrion, Parexel, clinical site employee, or their close relative regardless of direct involvement in research activities.

Investigators

Sponsor
KEDRION S.P.A

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